Develop, document, and execute verification test methods to evaluate performance metrics of complex, electromechanical medical systems.
Update test architecture with focus on Continuous Integration.
Setup and debug verification test apparatus and fixtures that include oscilloscopes, digital multimeters, force sensors, digital measurement systems, and other electronic measurement equipment.
Analyze multidimensional datasets using Python and Matlab scripts.
Write test reports following proper SOP and QA procedures.
Release components, test fixtures, and documents in Agile.
Develop and perform test method validations.
Specify and purchase measurement equipment and maintain calibration records.
Required Skills
Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
Strong communication skills.
Good project management skills.
Self-starter, energetic, independent work ethic.
Self-starter who works with minimal supervision and the ability to work in a team of diverse skill sets.
To learn new skills and grow competencies.
Ability to work in a team-oriented, collaborative environment.
Required Experience
1 to 3 years of experience in the medical device industry highly preferred.
At least 3 years of experience in the Pharmaceutical or Bio-Pharmaceutical Industries.